Regulatory Affairs Pharmacist/specialist:

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a **Regulatory Affairs Pharmacist/Specialist: (8-month Contract position) **in our **Johannesburg, South Africa** office.

Takeda is a global pharmaceutical leader with more than 50,000 professionals working together across 80 countries. We have an unwavering dedication to put people first and we live our values of **Takeda-ism**—Integrity, Fairness, Honesty, and Perseverance. We are united by our 240+ year legacy of research-based pharmaceuticals and our mission to strive toward **Better Health and a Brighter Future** for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission.

**ROLE OBJECTIVES**:
The position will be responsible for,
- Product portfolio management of registered products and products under review for registration in South Africa (SA) and relevant export territories.
- Dossier maintenance - submission of variations in line with relevant regulatory requirements (country-specific and global requirements).
- Regulatory control and compliance over labelling, packaging, advertising and promotion of medicines

**REQUIRED QUALIFICATIONS AND EXPERIENCE**:

- BPharm degree, BSc science degree or equivalent.
- 2-3 years’ experience in the registration of medicines and submission of NCE.
- Valid SAPC registration would be an advantage
- Strong learning agility, ability and willingness to stretch self-acquiring new skills and competencies

**ACCOUNTABILITIES**:

- Manage regulatory process for specific area, this includes but is not limited to:

- Compile new product submissions specializing in NCE, CTD and electronic submissions
- Compile clinical dossier meeting the requirements of the Regulatory Authority (RA) in SA and relevant export territories, within the given timelines, to gain product registration.
- Complete due diligence checks and evaluation of prospective dossiers
- Assist in the regulatory arrangements needed to place new products on the market.
- Assist with regulatory follow-up to facilitate faster registration submission and obtain faster approval
- Liaise with and provide answers to queries on clinical matters connected to the products both with RA and with the International Principals
- Manage updates and maintenance of all registration dossiers to maintain product licenses in SA and relevant export territories
- Ensure variations and changes made to the registration dossier is properly controlled update the internal systems
- Liaise and represent Takeda with the RA in SA and relevant export territories
- Liaise with principal and international suppliers regarding registration /regulatory requirements and changing policies.
- Other general Regulatory work e.g. comment of proposed guidelines / legislative changes
- Exercise regulatory control over the labelling, advertising and promotion of medicines.
- Ensure that variations and changes made to the registration dossier are properly controlled and maintained.
- Compliance:

- Ensure compliance with the Approved Registration Dossier to meet specifications in each country (incl. export territories).
- Ensure compliance with all the Acts controlling medicines in SA and relevant export territories
- Training:

- Perform internal training on product related issues, where required
- Ensure Staff and /or Representatives are trained in terms of the Law and other applicable legislation applicable to the promotion and sale of medicines, where required
- Audit & Compliance
- Ensure that business under control is meeting desired compliance levels.
- Support the Quality Management system with the implementation of SOP’s

**BUSINESS SKILLS AND KNOWLEDGE**
- Excellent communication skills (verbal, written and presentation)
- Problem solving
- Sound judgment
- Good negotiation skills
- Proficient in MS Office
- Ability to establish and foster excellent customer relationships
- Planning and organising skills

**CORE COMPETENCIES**
- Foster trust
- Embraces Diversity
- Execute plans
- Propose solutions
- Promote change
- Be open and receptive
- Continually develop

**LICENSES/CERTIFICATIONS**:

- Valid South African Driver’s license for motor vehicle.
- Own vehicle that can be used for business.

**Empowering Our People to Shine**

Takeda is committed to providing a safe and healthy working environment and to having a workforce that is as diverse as the patients we serve and the communities where we’re based. To achieve that inclusivity, we embrace and celebrate our differences, respecting and valuing each other regardless of race, color, sex, age, national origin, religion, gender identity, sexual orientation, disability or physical appearance. We create a diverse, inclusive, safe, open and collaborative working environment in which employees can contribute, perform